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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002535-24 | EudraCT Number |
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To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVARREST® Fibrin Sealant Patch | Experimental | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
|
| Standard of Care (SoC) | Other | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVARREST® Fibrin Sealant Patch | Biological |
| ||
| Standard of Care (SoC) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization | Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS. | Intraoperative, 4 minutes following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization | Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure. | Intraoperative, 10 minutes following randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Kocharian, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Site #13 | Birmingham | Alabama | 35294 | United States | ||
| Clinical Investigation Site #10 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27017161 | Result | Koea JB, Batiller J, Aguirre N, Shen J, Kocharian R, Bochicchio G, Garden OJ. A multicentre, prospective, randomized, controlled trial comparing EVARREST fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection. HPB (Oxford). 2016 Mar;18(3):221-8. doi: 10.1016/j.hpb.2015.12.006. Epub 2016 Feb 1. | |
| 26636489 |
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| ID | Title | Description |
|---|---|---|
| FG000 | EVARREST Fibrin Sealant Patch | EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). EVARREST™ Fibrin Sealant Patch |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
|
| Absolute Time to Hemostasis |
The absolute time to achieve hemostasis at or after 4 minutes from randomization. |
| Intraoperative, an average of 4.2 minutes following randomization |
| Incidence of Re-bleeding Events From the TBS During the Study Follow-up | Up to 60-days following surgery |
| Incidence of Adverse Events (AEs) | Up to 60-days following surgery |
| Incidence of Adverse Events That Were Potentially Related to Thrombotic Events | Number of participants with adverse events that were potentially related to thrombic events | Up to 60-days following surgery |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Clinical Investigation Site #16 | Chicago | Illinois | 60611 | United States |
| Clinical Investigation Site #12 | Chicago | Illinois | 60637 | United States |
| Clinical Investigation Site #15 | New Orleans | Louisiana | 70121 | United States |
| Clinical Investigation Site #9 | St Louis | Missouri | 63110 | United States |
| Clinical Investigation Site #11 | New York | New York | 10032 | United States |
| Clinical Investigation Site #14 | New York | New York | 10065 | United States |
| Clinical Investigation Site #8 | Philadelphia | Pennsylvania | 19107 | United States |
| Clinical Investigation Site #17 | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Investigation Site #3 | Melbourne | 3004 | Australia |
| Clinical Investigation Site #2 | Woodville South | 5011 | Australia |
| Clinical Investigation Site #1 | Auckland | 93-503 | New Zealand |
| Clinical Investigation Site #6 | Birmingham | B15 2TH | United Kingdom |
| Clinical Investigation Site #7 | Cambridge | CB2 0QQ | United Kingdom |
| Clinical Investigation Site #4 | Edinburgh | EH16 4SA | United Kingdom |
| Clinical Investigation Site #5 | Leeds | LS9 7TF | United Kingdom |
| Derived |
| Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21. |
| Standard of Care (SoC) |
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL). Standard of Care (SoC) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EVARREST Fibrin Sealant Patch | EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). EVARREST™ Fibrin Sealant Patch |
| BG001 | Standard of Care (SoC) | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL). Standard of Care (SoC) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| BMI (kg/m2) | Mean | Standard Deviation | kg/m^2 |
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| BMI (kg/m2) | Median | Full Range | kg/m^2 |
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| BMI (Grouped) | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization | Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS. | The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set. | Posted | Number | participants with hemostatic success | Intraoperative, 4 minutes following randomization |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization | Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure. | The proportion of subjects achieving hemostatic success at 10 minutes following randomization was evaluated as a secondary endpoint using the logistic model with treatment and site/institution included in the model. | Posted | Number | participants with hemostatic success | Intraoperative, 10 minutes following randomization |
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| Secondary | Absolute Time to Hemostasis | The absolute time to achieve hemostasis at or after 4 minutes from randomization. | Time to hemostasis (TTH), defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization was evaluated as a secondary endpoint. In one subject in the SoC group, manual compression was not maintained until the 4-minute endpoint, but was released early and a suture was applied, at which point the subject was hemostatic. | Posted | Median | Full Range | minutes | Intraoperative, an average of 4.2 minutes following randomization |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Re-bleeding Events From the TBS During the Study Follow-up | Posted | Number | participants | Up to 60-days following surgery |
|
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| Secondary | Incidence of Adverse Events (AEs) | Posted | Number | participants | Up to 60-days following surgery |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events That Were Potentially Related to Thrombotic Events | Number of participants with adverse events that were potentially related to thrombic events | Posted | Number | participants | Up to 60-days following surgery |
|
|
Adverse events were recorded from the time of randomization until 60 days following the study procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVARREST Fibrin Sealant Patch | EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). | 12 | 50 | 45 | 50 | ||
| EG001 | Standard of Care (SoC) | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL). | 16 | 52 | 50 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Localized Intraabdominal Fluid Collection | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Haematoma Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Liver Abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Subdiaphragmatic Abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Chemical Peritonitis | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Post-procedural Bile Leak | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Wound Decomposition | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acites | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Odema Peripheral | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Post-procedural Bile Leak | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Blood Lactic Acid Increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| International Normalized Ratio Increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Urine Output Decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Ethicon Clinical R&D | Ethicon, Inc. | 908-218-2492 | jbatill2@its.jnj.com |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| United Kingdom |
|
| Australia |
|
| Normal |
|
| Overweight |
|
| Obese |
|
| Morbidly Obese |
|
| Units | Counts |
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| Units |
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| Participants |
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